Patient respiratory mask with integrated microphone and method of patient communication utilizing the same

ABSTRACT

The present disclosure presents a patient respiratory mask that is configured to pick up patient speech from within the patient respiratory mask utilizing a microphone and to transmit that speech to a speaker or other communications device and a method of patient communication utilizing the same.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. application Ser. No.17/089,903, filed Nov. 5, 2020, which is a continuation of U.S.application Ser. No. 15/611,136, filed Jun. 1, 2017, which claimspriority to U.S. Provisional No. 62/353,099 filed Jun. 22, 2016, each ofwhich are incorporated herein by reference in their entirety.

BACKGROUND

The present disclosure relates patient respiratory masks, and inparticular, patient respiratory masks, such as continuous positive airpressure (CPAP) or other (e.g., bi-level positive airway pressure(BiPAP)) devices, said respiratory masks that include a microphone, themicrophone configured to interface with a wired or wireless speakerand/or a wired or wireless communications device, such as a telephone.

In a clinical setting, with a patient that requires the use of arespiratory mask that restricts the ability to communicate naturally,coherent conversation with visitors or via telephone is universallydifficult. This is due, at least in part, to the intervening plasticmaterial as well as to noise of the airflow and machinery.

Accordingly, there is a need in the art for a patient respiratory maskthat is configured to pick up patient speech from within the patientrespiratory mask or associated accessories, utilizing a microphone, andtransmitting that speech to an external speaker or other communicationsdevice.

SUMMARY

The above-described and other problems and disadvantages of the priorart are overcome or alleviated by the present patient respiratory maskthat includes a microphone, the microphone configured to interface witha wired or wireless speaker and/or a wired or wireless communicationsdevice, such as a telephone.

In exemplary embodiments, the microphone is a noise-cancellingmicrophone. In further embodiments, the microphone includes or isassociated with at least one noise filter. In further exemplaryembodiments, one or more of the microphone, speaker and communicationsdevice is in a wireless configuration.

In further exemplary embodiments, an on-board speaker is integrated intoa portion of the respiratory mask coupler. In further exemplaryembodiments, a speaker is external to the mask coupler.

In additional exemplary embodiments, the patient respiratory maskincludes an internal and/or coupler adapted noise cancelling microphonewith a short-range wireless (radio frequency) technology standard, e.g.,Bluetooth®, capability. In further exemplary embodiments, the microphonesignal is processed utilizing noise-cancelling sound processing. Inexemplary embodiments, the microphone is attached to or built into arespiratory mask or mask fluid delivery tube.

In additional exemplary embodiments, the respiratory mask includes acoupler between a fluid delivery tube and a facial mask portion, thecoupler including one or more of a microphone, speaker, wiring,processor, or communications device. In exemplary embodiments, one ormore of the preceding elements are embedded in or provided through aportion of the coupler. In further exemplary embodiments, one or more ofthe elements described herein are embedded in or provided through adevice connected to the coupler via power and/or signal wiring.

In further exemplary embodiments, the microphone is configured towirelessly transmit a patient's voice, via Bluetooth® technology, to aBluetooth® speaker in proximity to and in communication with theBluetooth® transmitter. In further exemplary embodiments, the microphoneis configured to wirelessly transmit a patient's voice, via Bluetooth®technology, to a Bluetooth®-enabled smartphone in proximity to and incommunication with the Bluetooth® speaker and/or the Bluetooth®transmitter. While a Bluetooth® speaker and an exemplary Bluetooth®smartphone are specifically described, the present disclosurecontemplates other Bluetooth® communications devices. And whileBluetooth® is specifically described, the present disclosurecontemplates other wireless technologies, including but not limited toWi-Fi.

The above-discussed and other features and advantages of the presentinvention will be appreciated and understood by those skilled in the artfrom the following detailed description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring now to the drawings, wherein like elements are numbered alikein the following FIGURES:

FIG. 1 is a rear elevation view of an exemplary respiratory maskincluding a microphone in accordance with exemplary embodiments of thepresent disclosure;

FIG. 2 is a perspective view of an exemplary respiratory mask utilizinga microphone coupler provided on the fluid delivery tube near therespiratory mask in accordance with exemplary embodiments of the presentdisclosure;

FIG. 3 is a perspective view of an exemplary coupler deviceincorporating a microphone, including a schematic of communicationscomponents for the coupler in accordance with exemplary embodiments ofthe present disclosure;

FIG. 4A is a perspective view of an exemplary clip-on accessoryincluding a microphone in accordance with the exemplary embodiments ofthe present disclosure;

FIG. 4B is a side elevation view of an exemplary clip-on accessoryincluding a microphone in accordance with the exemplary embodiments ofthe present disclosure;

FIG. 5 is a front elevation view of an exemplary wired tube andrespiratory mask coupler including a microphone in accordance withexemplary embodiments of the present disclosure; and

FIG. 6 is a side elevation view of exemplary tube and cord lengthssecured to one another via multiple harness clips in accordance withexemplary embodiments of the present disclosure.

DETAILED DESCRIPTION

As was noted above, the present disclosure relates to a patientrespiratory mask that includes a microphone disposed thereon, themicrophone is configured to interface with a wired or wireless speakerand/or a wired or wireless communications device, such as a telephone.While the following is described in reference to various exemplaryembodiments, the present disclosure is not so limited.

In some exemplary embodiments, the microphone is a noise-cancellingmicrophone. In further embodiments, the microphone includes or isassociated with at least one noise filter. In further exemplaryembodiments, one or more of the microphone, speaker and communicationsdevice is wireless. It is to be understood that reference to acomponent, such as a microphone, speaker, etc., as being wireless ortransmitting wirelessly encompasses configurations wherein such deviceis connected to a component that includes a wireless transmitter and/orreceiver. Accordingly, any reference herein to a “wireless” componentshould be read to encompass such a construction.

In further exemplary embodiments, an on-board speaker is integrated intoa portion of the respiratory mask. In further exemplary embodiments, aspeaker is external to the mask.

As we have noted, in exemplary embodiments, the patient respiratory maskincludes an internal and/or coupler- or tube-adapted noise-cancellingmicrophone with wireless, e.g., Bluetooth®, capability. In exemplaryembodiments, the microphone is attached to or built into a respiratorymask, a coupler designed to attach to the mask tube interface, or maskfluid delivery tube (e.g., for oxygen, air or some other gas). Inadditional exemplary embodiments, the coupler includes one or more of amicrophone, a speaker, wiring, processor and a communications device. Inexemplary embodiments one or more of the preceding elements are embeddedin or provided through a portion of the coupler.

As we have also noted, further exemplary embodiments, the microphonewirelessly transmits a patient's voice, via Bluetooth® technology, to aBluetooth® speaker in proximity to and in communication with theBluetooth® transmitter. Reference herein to a “Bluetooth®” device refersto a device that is enabled to use Bluetooth® technology.

In further exemplary embodiments, the microphone wirelessly transmits apatient's voice, via Bluetooth® technology, to a Bluetooth® smartphonein proximity to and in communication with the Bluetooth® speaker and/orBluetooth® transmitter. While a Bluetooth® speaker and an exemplaryBluetooth® smartphone are specifically described, the present disclosurecontemplates other Bluetooth® communications devices.

Referring now to FIG. 1 , one exemplary patient respiratory mask inaccordance with the present disclosure includes an exemplary microphoneprovided therein. In exemplary embodiments, the respiratory mask is aCPAP (or BIPAP) respiratory mask, shown generally at 10, with a maskportion 12 and a microphone 14 that is incorporated within a fluidairspace, shown generally at 16, of the mask 10 near the mouth (notshown) of a patient. The exemplary mask also includes a fluid deliverytube 18 and at least one mask inlet 20.

In exemplary embodiments, the microphone 14 is mounted on or is providedwithin the material of the mask. In another exemplary embodiment, themicrophone is provided in a separate microphone tube (not shown) thatmay extend at least partially into the fluid airspace of the mask 10. Infurther exemplary embodiments, the microphone tube is at least partiallysealed, for example via plastic or a membrane that is at leastmoderately transparent to sound but that also separately maintains theintegrity of the fluid airspace 16 within the respiratory mask 10. Suchan exemplary microphone tube may be provided within or be mounted to therespiratory mask 10, a fluid delivery tube 18, or any coupler 22 orportions intermediate the fluid delivery tube 18 the respiratory mask10.

Referring now to FIG. 2 , another exemplary patient respiratory mask 10incorporates such Bluetooth® microphone 14 into a coupler 22 that ispositioned between the fluid delivery tube 18 and the respiratory mask10. In exemplary embodiments, the coupler 22 is sized and configured toprovide a friction fit for the mask inlet 20 on one side and for thefluid delivery tube 18 on the other side. Referring to FIG. 3 , anexemplary coupler 22 includes a mask inlet side, shown generally at 32,a fluid supply tube side, shown generally at 34, with bulk air flowtraversing the interior of the tube generally at the arrows of 36.

In an exemplary embodiment, a microphone 14 is separated from the bulkair flow 36 by a filter 38, which may be configured to filter one ormore sound characteristics or to simply shield the microphone from bulkair flow. The filter 38 may be a membrane, acoustic mesh, or any otherconvenient sound transmitting material.

In the illustrated exemplary embodiment, the microphone is illustratedas being operatively connected to a microphone pre-amplifier 40, anequalization component 42 (for example an analog to digital converter(ADC) and digital signal processor (DSP)), a Bluetooth® transmitter 44,a sound output component, such as a digital to analog converter (DAC),amplifier (Amp) and speaker 45, an antenna 46 and a power supply 47,such as a battery or wired power adapter. These components areillustrated in this exemplary embodiment as being both connected to themicrophone and as being housed on a protruding portion 48 of the coupler22. However, it should be recognized that the microphone may beconfigured on-board the coupler 22 with more or fewer associatedcomponents, with some components or processes omitted or performedelsewhere, e.g., on the exterior of the coupler 22, remote from thecoupler 22, etc.

In exemplary embodiments, the coupler may be configured to attach to thefluid delivery tube, regardless of any variation in tube diameter (e.g.,differences in configurations warranting use of a 19 mm standard tubevs. a 15 mm thin tube). Thus, exemplary embodiments provide a universalattachment (e.g., as a clip on, etc., as shown in FIG. 4 ) configured tofit a wide array of tubes and breathing apparatuses.

In other exemplary embodiments, the microphone or other electroniccomponents are configured to attach externally (for example as aclip-type attachment, among others) to the respiratory mask 10 but inclose proximity to the patient's fluid airspace (see 16 in FIG. 1 ).Referring now to FIG. 4A, a clip 50 is illustrated with a microphone 14provided on an underside of the clip. In exemplary embodiments, the clip50 also interfaces with a power and signal wire 54 via a port 56. Whilesuch a clip may be configured to attach anywhere that is convenient toplace the microphone 14 near a sound transmitting surface, for examplethe mask inlet 20 of mask 10 or an exterior portion of a coupler 22,FIG. 4 illustrates provision of the clip 50 over a portion of the fluiddelivery tube 18, with the microphone against or proximate the materialof the fluid delivery tube to pick up sound vibrations transmittedthrough the fluid delivery tube. It should be recognized that while FIG.4 illustrates a wired configuration, the microphone can also beconfigured with a battery and a wireless (e.g., Bluetooth®) transmitter.FIG. 4B illustrates an exemplary side elevation view of the clip 50,with microphone 14 positioned to be near fluid delivery tube 18 in aninstalled position.

Referring now to FIG. 5 , an exemplary fluid delivery tube 18 isillustrated as including an integrated coupler 22 that incorporates anexemplary microphone 14 (see FIG. 2 ) therein and is attachable to orintegral to respiratory fluid delivery tube 18. An exemplary power cord24 runs at least along a portion of the fluid delivery tube 18 to themicrophone 14 (which may be configured in a wired or wireless, e.g.,Bluetooth®, arrangement). As we have noted above, the coupler may alsoinclude other components, such as processing or filtering components, awireless transmitter, etc., in addition to or alternative to themicrophone, such as a speaker, wiring or any other type ofcommunications device.

In further exemplary embodiments, the microphone 14 may be configured asa wired microphone utilizing the exemplary cord 24 or another cord fordata transmission. In additional exemplary embodiments, the microphonemay be wireless and may be connected to a battery source, with no cordsrunning along a portion of the fluid delivery tube 18.

In further exemplary embodiments, an exemplary cord can be configuredwith one or more clips to secure it to the fluid delivery tube 18 or asan integral part of the fluid delivery tube 18, for example embedded orpermanently attached to the fluid delivery tube 18 or to a fluiddelivery tube wiring harness. Exemplary wire harness clips 62 areillustrated as attaching a cord 24 to fluid delivery tube 18 in FIG. 6 .In exemplary embodiments, the cord 24 is configured as a wiring harnesssecured at one or more places via harness clips 62, with the cordconnectable to a coupler 22 (as in FIGS. 2 and 3 ) or a mask (as in FIG.1 ).

For any wired configurations, the remote (from the mask) end of the cord24 may be configured to connect to additional components, such as aspeaker, processor, network, power, etc.

Exemplary embodiments contemplate non-rechargeable, battery-drivenBluetooth® microphones as well as rechargeable battery Bluetooth®microphones with a port or cable or wireless connection for rechargingvia an external power source, or directly corded microphones (providingconstant power).

In exemplary embodiments, the patient respiratory mask, inclusive of theBluetooth® microphone, is configured as a disposable device. Inexemplary embodiments, one or more components, such as the mask, coupleror hose, is configured as a disposable product to have a pre-determinedworking lifetime. In further exemplary embodiments, life indicators maybe used to identify an end of the working respirator mask lifetimedetermined from unpacking from a sterile field. In a further exemplaryembodiment, a battery in communication with the microphone is configuredto expire or switch off at end of the working respirator mask lifetime.

In other exemplary embodiments, the patient respiratory mask and/orfluid delivery tube is configured to be reusable, with the Bluetooth®microphone being at least partially water resistant. In furtherexemplary embodiments, the Bluetooth® microphone is waterproof or ishoused in a waterproof enclosure. In such exemplary embodiments, thepatient respiratory mask and/or tube may be configured with a Bluetooth®microphone configured to withstand cleaning via use of cleaning agents,e.g., enzymatic cleaning solutions, rinses, disinfectants andpasteurizations, among others. Further exemplary embodiments provide aBluetooth® microphone or microphone enclosure configured to withstandthe effects of cleaning as well as effects of drying at utility or otherstations.

Exemplary embodiments of the present disclosure also relate to anexemplary system with a patient respiratory mask positioned on apatient, the respiratory mask including a Bluetooth® noise cancellingmicrophone within or adjacent to the patient's fluid airspace, and atleast one external Bluetooth® communications device. In the illustratedexemplary embodiment, a Bluetooth® speaker and a Bluetooth® smartphoneare illustrated as being in communication with the microphone. Inexemplary embodiments, at least the microphone and one externalBluetooth® communication device are pre-paired to permit instantaneousconnection when within the proper proximity. In other exemplaryembodiments, the Bluetooth® microphone continually broadcasts pairinginformation and is open for pairing subject to confirmation by theexternal Bluetooth® communications device. Other exemplarycommunications devices are also contemplated herein, including, withoutlimitation, personal assistants, including media platforms such as theGoogle Home or Amazon Echo/Tap/Alexa, etc., that also might have aspeaker that is usable for patient communications as well as the abilityto accept commands for any of its functions (e.g., to play music or callsomeone via voice over Internet protocol or other means). Otherexemplary embodiments have a speaker integral with the mask, coupler orfluid tube. Additionally, other communications protocols may be used inconjunction with the above-described wireless protocols and others(e.g., non-Bluetooth® wireless protocols), such as Wi-Fi.

As we have noted, a speaker or other communications device may beexternal or may be integrated into the mask portion, coupler or fluiddelivery tube. Additionally, such speaker or other communications devicecan be configured to communicate wirelessly or in a wired mode. In afurther exemplary aspect, both modes are configured, and the system isconfigured to automatically or manually (via a switch or application)switch modes.

In further exemplary embodiments an application running on a processorcontrols one or more aspects of the system, including withoutlimitation: speaker or communications device mode; noisefiltering/canceling or processing parameters; microphone parameters;wireless connections to devices; and monitoring for new devices inrange.

In further exemplary embodiments, power for one or more components issupplied by a power cable with any convenient terminal ends, for example110 volt outlet termination, USB, lightning connector, etc.

In other exemplary embodiments, bone induction or an in-ear, behind theear or in-canal hearing aid provides or delivers a sound signal to thepatient, with bone induction or hearing aid equipment wired to orwirelessly communicating with the respiratory mask system.

In exemplary embodiments, when the user (patient) of the respiratorymask speaks, their voice will be captured by the noise cancelingmicrophone as the sound hits the interior structure of the mask and/ortravels down the tube. Once the voice is captured in the device, it istransferred via Bluetooth® technology to a free-standing speaker wheretheir voice will be amplified. In other exemplary embodiments, the voiceis transferred to a speaker on the mask, coupler or tube where the voicewill be amplified.

In other exemplary embodiments, the system is configured to distinguishbetween direct human interaction (conversation) and digital interaction(e.g., voice signals from a mobile phone) and automatically switchoutput to one of plural possible wireless communications devicesdepending on the detected signal. Alternative automatic or manualswitching is further contemplated herein with regard to exemplaryembodiments, for switching between a nearby Bluetooth® speaker and acommunications device (e.g., a mobile telephone, facilitating patientconversation with a remote individual). In other embodiments, multipleBluetooth® devices may be connected at the same time via bridgingcapabilities. Such a switching or bridging capability may be e.g.,provided alongside the microphone or anywhere in range of the Bluetooth®microphone. In other embodiments, multiple Bluetooth® devices may beconnected at the same time via multiple connections or modes.

It will be apparent to those skilled in the art that, while exemplaryembodiments have been shown and described, various modifications andvariations can be made to the invention disclosed herein withoutdeparting from the spirit or scope of the invention. Also, the exemplaryimplementations described above should be read in a non-limitingfashion, both with regard to construction and methodology. Accordingly,it is to be understood that the various embodiments have been describedby way of illustration and not limitation.

What is claimed is:
 1. A patient respiratory mask, comprising: a maskportion defining an interior airspace, the mask portion comprising aninlet to the interior airspace; a fluid delivery tube in fluidcommunication with the interior airspace to provide positive airpressure from a positive air pressure device when connected with thefluid delivery tube; a coupler between the inlet of the mask portion andthe fluid delivery tube, the fluid delivery tube connecting with aportion of the coupler substantially below the inlet to the interiorairspace of the mask portion; and a housing protruding at leastpartially from the coupler, the housing including a microphone and aspeaker arranged at opposing portions of the housing, with the speakerbeing arranged in a portion of the housing protruding from the coupler,the housing including a microphone tube extending at least partiallyinto the interior airspace of the mask portion to position themicrophone within the interior airspace, to pick up speech from thepatient; the microphone being operatively connected to the speaker byone or more of: an equalization component including an analog to digitalconverter and a digital signal processor; and a sound output componentincluding a digital to analog converter, to amplify the speech of thepatient over the speaker.
 2. The patient respiratory mask of claim 1,further comprising a processor controlling one or more of microphoneparameters, noise filtering, noise cancelling, and noise processing. 3.The patient respiratory mask of claim 2, wherein the processor isconnected with the housing by a cord securable to the fluid deliverytube, wherein a first end of the cord is connected with the housing anda second end of the cord is connected with the processor at a locationremote from the mask portion.
 4. The patient respiratory mask of claim1, wherein the microphone is operatively connected to the speaker by awired connection.
 5. The patient respiratory mask of claim 4, whereinthe microphone and the operatively connected speaker are supplied withpower by a battery or power cable.
 6. The patient respiratory mask ofclaim 1, wherein the microphone is operatively connected to the speakerby a wireless connection.
 7. The patient respiratory mask of claim 1,wherein the microphone comprises a filter configured to shield themicrophone from bulk air flow or to filter one or more soundcharacteristics.
 8. The patient respiratory mask of claim 1, wherein thepositive air pressure device is a continuous positive air pressure(CPAP) or bi-level positive air pressure (BiPAP) device.
 9. A patientrespiratory mask, comprising: a mask portion defining an interiorairspace, the mask portion comprising an inlet to the interior airspace;a fluid delivery tube in fluid communication with the interior airspaceto provide positive air pressure from a positive air pressure devicewhen connected with the fluid delivery tube; a coupler between the inletof the mask portion and the fluid delivery tube, the fluid delivery tubeconnecting with a portion of the coupler substantially below the inletto the interior airspace of the mask portion; a microphone providedthrough a portion of the coupler, wherein the microphone is positionedwithin the interior airspace when provided through the coupler to pickup speech from the patient; and a speaker operatively connected with themicrophone to amplify the speech of the patient; wherein the microphoneand speaker are arranged in a housing provided through a portion of thecoupler, wherein the microphone and speaker are arranged atopposing-portions of the respective housing, with the speaker arrangedin a portion of the housing protruding at least partially from thecoupler, and wherein the microphone is operatively connected to one ormore of: an equalization component including an analog to digitalconverter and a digital signal processor; and a sound output componentincluding a digital to analog converter, to amplify the speech of thepatient over the speaker.
 10. The patient respiratory mask of claim 9,wherein the microphone and speaker are operatively connected by a wiredconnection.
 11. The patient respiratory mask of claim 9, wherein thehousing comprises a filter configured to shield the microphone from bulkair flow or to filter one or more sound characteristics.
 12. The patientrespiratory mask of claim 9, further comprising a processor controllingone or more aspects of the patient respiratory mask including one ormore of: speaker or communications device mode, noisefiltering/canceling or processing parameters, microphone parameters,wireless connections to external devices, and monitoring for newexternal devices in range.
 13. The patient respiratory mask of claim 9,further comprising a processor controlling one or more of microphoneparameters, noise filtering, noise cancelling, and noise processing. 14.The patient respiratory mask of claim 13, wherein the processor isconnected with the housing by a cord securable to the fluid deliverytube, wherein a first end of the cord is connected with the housing anda second end of the cord is connected with the processor at a locationremote from the mask portion.
 15. The patient respiratory mask of claim9, wherein the positive air pressure device is a continuous positive airpressure (CPAP) or bi-level positive air pressure (BiPAP) device.
 16. Acommunications system, comprising: a respiratory mask for wearing by apatient, the respiratory mask comprising: a mask portion defining aninterior airspace, the mask portion comprising an inlet to the interiorairspace; a fluid delivery tube coupled with the inlet by a coupler, thefluid delivery tube connecting with a portion of the couplersubstantially below the inlet to the interior airspace of the maskportion, whereby the fluid delivery tube is in fluid communication withthe interior airspace to provide positive air pressure from a positiveair pressure device connected with the fluid delivery tube; a housing,the housing comprising: a microphone, and a speaker operativelyconnected with the microphone by a wired connection, the housingenclosing the microphone and speaker, the microphone and speakerarranged at opposing portions of the housing, wherein the microphone isprovided within a tubular portion of the housing extending at leastpartially into the interior airspace of the mask portion to position themicrophone in close proximity to the patient's mouth, and wherein thetubular portion of the housing is provided through a portion of thecoupler; and a processor controlling one or more aspects of the system,wherein the processor is connected with the housing by a cord securableto the fluid delivery tube, wherein a first end of the cord is connectedwith the housing and a second end of the cord is connected with theprocessor remote from the mask portion.
 17. The system of claim 16,wherein the speaker and microphone are operatively connected by one ormore of: an equalization component including an analog to digitalconverter and a digital signal processor; and a sound output componentincluding a digital to analog converter, to amplify the speech of thepatient over the speaker.
 18. The system of claim 16, wherein thehousing comprises a filter configured to shield the microphone from bulkair flow or to filter one or more sound characteristics.
 19. The systemof claim 16, wherein the tubular portion of the housing is at leastpartially sealed by a plastic or a membrane at least moderatelytransparent to sound, and wherein the plastic or membrane maintains theintegrity of the interior airspace of the respiratory mask.
 20. Thesystem of claim 16, wherein the one or more aspects of the systemcontrolled by the processor include one or more of: speaker orcommunications device mode, noise filtering/canceling or processingparameters, microphone parameters, wireless connections to externaldevices, and monitoring for new external devices in range.
 21. Thesystem of claim 16, wherein the one or more aspects of the systemcontrolled by the processor include one or more of: microphoneparameters, noise filtering, noise cancelling, and noise processing. 22.The system of claim 16, wherein the positive air pressure device is acontinuous positive air pressure (CPAP) or bi-level positive airpressure (BiPAP) device.